Choosing a CRO for clinical trials in Ireland and Europe

How are clinical trials authorised in the EU now?

The Clinical Trials Regulation (EU) No 536/2014 (CTR) applies to all clinical trials of medicinal products conducted in the Union. It harmonises assessment and supervision of trials across the EU, according to the European Medicines Agency. Sponsors submit one online application through the Clinical Trials Information System (CTIS), and from 31 January 2025 any trial approved under the old Directive that was still running had to comply with the Regulation.

Each application has two parts. Part I covers the protocol, investigator's brochure and investigational medicinal product dossier, assessed under the lead of a Reporting Member State. Part II covers informed consent, investigator and site suitability, indemnity and data protection, assessed nationally. Each Member State Concerned then issues a single national decision, and a trial cannot start in a country until that decision is issued (HPRA guide).

The obligations continue after approval. Under CTR Article 37, the sponsor must submit a summary of results to the EU database within one year of the end of the trial in all Member States concerned, with a lay summary. Ask any CRO how it tracks this deadline.

What is different about running a trial in Ireland?

The Health Products Regulatory Authority (HPRA) is the competent authority. It worked with the National Office for Research Ethics Committees and the Department of Health on a coordinated procedure, and the National Office has established four National Research Ethics Committees (NRECs) for clinical trials. Since 31 January 2023, applications go through CTIS rather than directly to the HPRA or the NREC-CT.

For site capacity, the HRB National Clinical Trials Office (NCTO) is funded through the Health Research Board and Enterprise Ireland and coordinates a network of seven university-linked clinical research facilities and centres. It offers industry sponsors feasibility, start-up support and recruitment tracking. Ask CROs how they work with it.

Medtech sponsors follow a different route. Clinical investigations of devices fall under the Medical Devices Regulation (EU) 2017/745, with applications made to the HPRA and to the National Research Ethics Committee for Medical Devices (HRB NCTO). A CRO strong in CTIS medicines work is not automatically strong in device investigations, so check this separately.

What stays with the sponsor and what can a CRO take on?

CTR Article 71 allows a sponsor to delegate any or all of its tasks in a written contract, without prejudice to the sponsor's responsibility for the safety of subjects and the reliability of the data. ICH E6(R3), which came into effect in the EU on 23 July 2025, says the same: transferred activities must be documented in an agreement, anything not transferred stays with the sponsor, and the ultimate responsibility remains with the sponsor.

E6(R3) also expects the sponsor to assess the suitability of a service provider before selecting it, to have access to information such as SOPs and performance metrics, and to oversee important activities, including those the CRO subcontracts. The HPRA guide notes that its inspectors review how duties were distributed, whether written agreements define roles, and whether the sponsor has mechanisms to maintain oversight.

Full-service, specialist or functional service provider?

CRO business models are not defined in law, but most sponsors choose between three broad options:

• Full-service CRO: one provider runs most outsourced activities, from start-up and monitoring to data management and safety. This suits small sponsors without an EU operations team, but it concentrates risk in one vendor.
• Specialist or niche CRO: depth in a therapeutic area, a trial type such as late phase or rare disease, or a region. Often a better fit when patient access or site relationships are the main challenge.
• Functional service provider (FSP): the CRO supplies staff for defined functions, such as monitoring or biostatistics, under your processes. This suits sponsors with strong internal systems who want to keep control.

Late phase and Phase IV work needs extra care. A post-authorisation study may be a clinical trial under the CTR, sometimes a low-intervention trial if the product is authorised, used per its marketing authorisation or evidence-based, and extra procedures add no more than minimal risk. The CTR does not apply to non-interventional studies. Ask any late phase CRO how it classifies studies and who in the team makes that call.

How to choose a CRO in Ireland: the criteria that matter

Questions to ask in a bid defence

• Who exactly will run our study, and what share of their time is committed to it?
• Which CTIS applications has this team submitted recently, and what were the main requests for information?
• Which sites in Ireland and other target countries do you propose, and why those sites?
• How will you report serious breaches? The CTR requires reporting through CTIS within seven calendar days of the sponsor becoming aware (HPRA guide).
• Which activities will you subcontract, to whom, and will we see the agreements?
• What oversight reports and metrics will we receive, and how often?
• Can you act as our EU legal representative, and is that included in the price?

Red flags to watch for

• A senior team at the pitch that is not the team named in the contract.
• Vague answers on CTIS experience, or no clear explanation of the Part I and Part II split.
• Recruitment projections with no named sites or historical data behind them.
• Reluctance to share SOPs, metrics or subcontractor details, which E6(R3) expects sponsors to be able to access.
• A low headline price paired with an open-ended change-order process.
• Contract language implying the CRO takes on the sponsor's legal responsibility. Under the CTR and E6(R3), it cannot.

Where does Ireland fit in European trials?

Ireland is a small market, so it is usually one country in a multinational application rather than the only one. The HPRA reports that it issued 82 authorisations under the Clinical Trials Regulation during 2024. For sponsors, the practical draws are one national decision covering science and ethics, and a CRF network coordinated by the HRB NCTO.

Before you shortlist CROs, it helps to see where similar trials already run. Priya Life Science publishes free registers of clinical trials in Ireland and clinical trials in Europe, an Ireland clinical trials dashboard, and sponsor pages that show which companies run trials where. These draw on public registers and are a scoping aid, not a feasibility study.

Getting started with a CRO shortlist

Start with your obligations: map what you will keep in-house, what you will transfer in writing, and how you will oversee it. Then test CROs on evidence, not slides: CTIS history, named sites, subcontractors and the people who will actually do the work. If you would like help, Priya Life Science's independent CDMO and CRO sourcing service can shortlist CROs in Ireland and make introductions. There is no cost to enquire, and the final choice and contract stay with you.